Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis
The purpose of this study is to compare the effect of rosiglitazone versus placebo on soluble proinflammatory markers in peritoneal fluid of women with endometriosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
|Official Title:||Endometriosis: Immunomodulation|
- Peritoneal fluid cytokine concentrations
- Cytokine quantification
- Gene array analyses
|Study Start Date:||July 2005|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
The overall goal of this proposal is to assess modulation of immune mechanisms in endometriosis. Endometriosis is a common ailment affecting approximately five million reproductive-aged American women. We will test the efficacy of a novel immunomodulatory drug (peroxisome proliferator activated receptor gamma, PPAR-gamma, agonist), rosiglitazone, to reduce peritoneal fluid cytokine concentrations in women with endometriosis compared with placebo controls (randomized controlled trial). Based on prior studies done by the investigator highlighting the major role of cytokines and the immune system in the genesis or propagation of endometriosis, these experiments could lead to improved translational treatment strategies and a better understanding of endometriosis. Acting through PPAR-gamma, TZDs inhibit proinflammatory cytokines as well as NF-kB, an important nuclear transcription factor for the production of many cytokines. Accordingly, since human endometrial epithelial and stromal cells contain PPAR-gamma, we felt it would be useful to evaluate the influence of a PPAR-gamma ligand, rosiglitazone, on the concentration of specific peritoneal fluid cytokines.
Comparison: After the pre-trial screening, eligible subjects with presumed endometriosis and age 18-45 will be consented and randomly assigned to receive either placebo (control) or rosiglitazone, Avandia®, 4 mg daily for 2 weeks. Peritoneal fluid will be collected at the time of surgery and the volume measured. All patients enrolled in the study will have their surgery during the follicular phase of the cycle in order to minimize differences in volume and cytokine concentration due to the cyclical changes. The primary measure will be the peritoneal fluid concentration comparisons of the two groups assessing six different cytokines: interleukin-1 beta, RANTES, tumor necrosis factor-alpha and vascular endothelial growth factor.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121953
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Dan I. Lebovic, MD, MA||University of Michigan|